[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635911":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":56,"collaborators":26,"id":58,"slug":26,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":26,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FTD Conversational AI Intervention","EXPERIMENTAL","Participants in this arm will use the Fudan Tinnitus Doctor (FTD) system, a multi-agent large language model-based conversational AI platform that delivers personalized tinnitus management strategies based on cognitive behavioral therapy principles.",[13],"Device: Fudan Tinnitus Doctor (FTD) System",{"label":15,"type":16,"description":17,"interventionNames":18},"Digital Education Control","ACTIVE_COMPARATOR","Participants in this arm will receive access to a non-conversational digital program consisting of static educational materials and a fixed-response question-and-answer module related to tinnitus, sleep, and mental health.",[19],"Device: Non-conversational Digital Education Program",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Fudan Tinnitus Doctor (FTD) System","The FTD system is a multi-agent conversational artificial intelligence platform that delivers personalized tinnitus management through a secure web-based interface. It supports multimodal interaction (text and voice) and integrates a large language model, retrieval-augmented generation, and multi-agent collaboration to provide cognitive behavioral therapy-based interventions, including psychoeducation, cognitive restructuring, relaxation techniques, and sleep hygiene guidance.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Non-conversational Digital Education Program","Participants in this arm will receive access to a non-conversational digital tinnitus self-management program delivered through the same secure web-based interface as the intervention group. The program provides static educational materials and a fixed-response question-and-answer module related to tinnitus, sleep, and mental health.",[15],[32],{"name":33,"affiliation":34,"role":35},"Shan Sun","Eye and ENT Hospital of Fudan University","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Shan Sun, Ph.D","CONTACT","+86-021-64377134-2033","sunshine7896@126.com",[43],{"facility":44,"status":26,"city":45,"state":26,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department","Shanghai","200031","China",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100635911",false,"NCT07558837","Fudan Tinnitus Doctor for Tinnitus Management","A Multi-agent Large Language Model Conversational AI for Tinnitus Management: The Fudan Tinnitus Doctor Randomized Controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of subjective tinnitus confirmed by a qualified investigator.\n2. Tinnitus duration ≥ 3 month prior to screening.\n3. THI score of ≥ 18\n4. Aged between 18 and 70 years\n5. The ability to use a smartphone: Both groups will receive therapeutic support and disease management primarily through a mobile application or web-based platform. This requires functional ability to operate the provided software and willingness to engage with the digital intervention protocol.\n6. Perceptibility: Tinnitus is present and recognizable by the participant under ordinary daily conditions (not only in quiet environments).\n7. Compliance and consent: Participant is assessed by the Investigator as able to understand study procedures, voluntarily agrees to participate, is willing to comply with all trial-related requirements, and provides signed informed consent prior to performance of any protocol-specified procedure.\n\nExclusion Criteria:\n\n1. Acute-phase tinnitus (duration \\\u003C 3 month or tinnitus secondary to acute otologic events).\n2. Pulsatile or objective tinnitus.\n3. Unstable symptoms: Fluctuating tinnitus loudness at screening or baseline.\n4. Psychiatric contraindication: History or current presence of severe psychiatric disorders (e.g., major depressive disorder with recent suicidality, schizophrenia) that, in the opinion of the Investigator, may interfere with study participation or data validity.\n5. Testing limitations: Inability to adequately complete tinnitus testing procedures or comply with study assessments.\n6. Prior therapy exposure: Previous history of sound therapy specifically for tinnitus management.\n7. Concurrent treatments: Ongoing psychotherapy for conditions such as anxiety or depression, or any other psychological treatment that may interfere with the study endpoints.\n8. Concurrent trial participation: Active participation in another interventional research study that, in the opinion of the Investigator, could affect tinnitus symptoms or interact with study procedures.\n9. Investigator judgment: Any condition (medical, surgical, psychiatric, or social) or factor which, in the Investigator's judgment, renders the subject unsuitable for participation, places the patient at higher risk, or may interfere with compliance or scientific validity of the trial.","ALL","18 Years","70 Years",{"count":68,"type":69},256,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to evaluate whether a conversational artificial intelligence-based digital intervention can improve symptoms in adults with chronic subjective tinnitus.\n\nThe main questions it aims to answer are:\n\nDoes the Fudan Tinnitus Doctor (FTD) system reduce tinnitus severity as measured by the Tinnitus Handicap Inventory (THI).\n\nDoes the FTD system improve sleep quality, anxiety, depression, and overall patient-reported outcomes.\n\nResearchers will compare the FTD system to a non-conversational digital education program to determine whether the AI-based intervention provides greater clinical benefits.\n\nParticipants will:\n\nUse either the FTD conversational AI system or a static digital education program for 30 days.\n\nComplete standardized questionnaires assessing tinnitus severity, sleep, mood, and overall improvement at baseline, Day 14, and Day 30.\n\nEngage with the digital platform for tinnitus self-management.",[75],"Tinnitus","NOT_YET_RECRUITING","2026-05-04",{"date":79,"type":80},"2026-05-07","ACTUAL",{"date":82,"type":69},"2026-05-01",{"date":84,"type":69},"2027-05-30",{"name":5,"class":6},1]